Pa Meyi 9, 2022, chilengezo choyambirira cha FDA chidalemba Glanbia Performance Nutrition (Manufacturing) Inc. pakati pamakampani omwe adalandira makalata ochenjeza.M'chilengezo chosinthidwa chomwe chinatumizidwa pa Meyi 10, 2022, Glanbia idachotsedwa pa chilengezo cha FDA ndipo sichinatchulidwenso m'makampani omwe akulandira makalata ochenjeza.
Silver Spring, MD—Bungwe la Food and Drug Administration (FDA) lapereka makalata ochenjeza kwa makampani 11 chifukwa chogulitsa zakudya zosayenera.FDA inanena kuti makalata akutumizidwa pazifukwa zosiyanasiyana, kuphatikizapo:
Zina mwazowonjezera zili ndi zakudya zatsopano (NDIs) zomwe bungweli silinalandire zidziwitso zofunikira za premarket NDI.
Zina mwazowonjezera ndi mankhwala, ngakhale zilibe chilolezo, chifukwa zimapangidwira kuti zigwiritsidwe ntchito pochiritsa, kuchepetsa, kuchiza, kapena kupewa matenda.Pansi pa Federal Food, Drug, and Cosmetic Act, zinthu zomwe zimafunidwa kuti zizindikire, kuchiritsa, kuchiza, kuchepetsa, kapena kupewa matenda ndi mankhwala ndipo zimatsatira zofunikira zomwe zimagwira ntchito pamankhwala, ngakhale zitalembedwa kuti ndizowonjezera zakudya, ndipo nthawi zambiri zimafunikira. kuvomerezedwa ndi FDA.
Zina mwazowonjezera zikuyimiridwa kuti ndizowonjezera zakudya zopanda chitetezo.
Makalata ochenjeza anatumizidwa kwa:
- Advanced Nutritional Supplements, LLC
- Exclusive Nutrition Products, LLC (Black Dragon Labs)
- Assault Labs
- IronMag Labs
- Killer Labz (Performax Labs Inc)
- Complete Nutrition LLC
- Max Minofu
- New York Nutrition Company (American Metabolix)
- Nutritional Sales ndi Customer Service LLC
- Malingaliro a kampani Steel Supplements, Inc.
FDA inanena kuti zowonjezera zomwe zimagulitsidwa ndi makampani omwe atchulidwa pamwambapa ali ndi chimodzi kapena zingapo mwa izi:
- 5-alpha-hydroxy-laxogenin
- higenamine
- Higenamine HCl
- hordenine
- hordenine HCl
- octopamine.
FDA idanenanso kuti yadzutsa nkhawa zingapo mwa zosakaniza izi, ndipo idanenanso za zotsatira zoyipa za higenamine pamtima.
Bungweli lidawonjezeranso kuti silinawunike ngati zinthu zomwe sizinavomerezedwe zomwe zili ndi makalata ochenjezawa ndizothandiza pazomwe akufuna, mlingo woyenera ungakhale wotani, momwe angagwirizanitse ndi mankhwala ovomerezedwa ndi FDA kapena zinthu zina, kapena kukhala ndi zotsatira zowopsa kapena nkhawa zina zachitetezo.
Makampani ochenjezedwa ali ndi masiku 15 ogwira ntchito kuti auze FDA momwe izi zidzayankhidwe, kapena kupereka malingaliro ndi chidziwitso chofotokozera chifukwa chomwe zinthuzo sizikuphwanya lamulo.Kukanika kuthana ndi nkhaniyi moyenera kungayambitse milandu, kuphatikizapo kulanda katundu ndi/kapena kuletsedwa.
Machenjezo aposachedwa, omwe adatumizidwa pa Meyi 9, akubwera patangopita masiku ochepa a FDA atatumiza makalata ochenjeza kumakampani asanu kuti agulitse zinthu zolembedwa kuti zili ndi delta-8 tetrahydrocannabinol (delta-8 THC) m'njira zomwe zimaphwanya Federal Food, Drug, ndi Cosmetic Act (FD&C Act).Malembowa akuwonetsa koyamba kuti machenjezo aperekedwa pazinthu zomwe zili ndi delta-8 THC, zomwe FDA idati zili ndi psychoactive komanso kuledzera ndipo zitha kukhala zowopsa kwa ogula.
Nthawi yotumiza: May-19-2022